Secondary Debulking Surgery +/- Hyperthermic Intraperitoneal Chemotherapy in Stage III Ovarian Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by The Netherlands Cancer Institute
Sponsor:
Information provided by:
The Netherlands Cancer Institute
ClinicalTrials.gov Identifier:
NCT00426257
First received: January 23, 2007
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

This study evaluates the efficacy and safety of the addition of hyperthermic intraperitoneal chemotherapy to secondary debulking surgery in stage III ovarian cancer.


Condition Intervention Phase
Ovarian Cancer
Procedure: Secondary debulking
Procedure: secondary debulking with intraperitoneal chemotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Randomised Clinical Trial for Stage III Ovarian Carcinoma Randomising Between Secondary Debulking Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy

Resource links provided by NLM:


Further study details as provided by The Netherlands Cancer Institute:

Primary Outcome Measures:
  • Duration of recurrence free survival.

Secondary Outcome Measures:
  • Toxicity and morbidity
  • Quality of life
  • Tumour response
  • Overall survival

Estimated Enrollment: 280
Study Start Date: February 2007
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Secondary debulking surgery with hyperthermic intraperitoneal chemotherapy
Procedure: secondary debulking with intraperitoneal chemotherapy
secondary debulking with intraperitoneal chemotherapy
Active Comparator: 2
Secondary debulking surgery
Procedure: Secondary debulking
Secondary debulking

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 76 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 76 years
  • Histological or cytological proven primary epithelial ovarian carcinoma or peritoneal cancer (PPSC) or fallopian tube carcinoma FIGO stage III, including serous papillary adenocarcinoma, mucinous adenocarcinoma and endometrioid adenocarcinoma.
  • In case of pleural effusion cytology should be negative for tumour cells
  • In case diagnosis is made based on cytology only (i.e. patients treated by primary chemotherapy) additional criteria apply:

    • Normal mammogram (< 6 weeks before first registration) and
    • Presence of pelvic mass and
    • CA 125 > 200 kU/l and
    • Serum CA125/CEA ratio > 25. If the serum CA125/CEA ratio is < 25, a barium enema or colonoscopy and gastroscopy or radiological examination of the stomach should be negative for the presence of a primary tumour of the digeste tract (< 6 weeks before registration) and
    • Omental cake or other metastases larger than 2 cm in the upper abdomen and/or regional lymph node metastasis irrespective of size (CT/MRI or ultrasound or laparoscopy)
  • Patients eligible for interval debulking for the following 2 reasons:

    • Primary debulking surgery not feasible due to tumour extension or general condition (patients treated by primary chemotherapy) or
    • Incomplete primary debulking with residual disease > 1 cm
  • In case of primary chemotherapy:

    • Chemotherapy consists of 3 courses of carboplatin or cisplatin combined with taxol
    • Following 2 cycles of chemotherapy at least a 30% decrease in the sum of largest diameter (LD) of target lesions taking as reference the baseline sum LD (RECIST criteria, see appendix 1)
  • In case of an incomplete primary debulking as indicated under 5 followed by chemotherapy:

    • Chemotherapy consists of 3 courses of carboplatin or cisplatin combined with taxol
  • General criteria:

    • Fit for major surgery, ASA 1 or ASA 2
    • WHO performance status 0-2
    • Written informed consent
    • Laboratory values: serum creatinine < 140 µmol/L; creatinine clearance > 60 ml/min (Cockroft formula); white blood cell count > 3.5 x 109/l; platelets > 100 x 109 /l
  • For quality of life studies:

    • Baseline questionnaires should be filled in before randomization

Exclusion Criteria:

  • History of breast cancer or previous malignancies within 5 years prior to inclusion, with the exception of radically excised basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426257

Contacts
Contact: Willemien J van Driel, MD +31 20 512 2975 w.v.driel@nki.nl

Locations
Netherlands
The Netherlands Cancer Institute Recruiting
Amsterdam, Netherlands, 1066CX
Principal Investigator: Willemien van Driel, MD         
Sponsors and Collaborators
The Netherlands Cancer Institute
Investigators
Study Chair: Willemien J van Driel, MD The Netherlands Cancer Institute
  More Information

No publications provided

Responsible Party: Dr. W. van Driel, Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT00426257     History of Changes
Other Study ID Numbers: M06OVH-OVHIPEC, 2006-003466-34, 2006-16
Study First Received: January 23, 2007
Last Updated: June 5, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by The Netherlands Cancer Institute:
Ovarian Cancer
stage III
hyperthermic intraperitoneal chemotherapy
debulking surgery
HIPEC

Additional relevant MeSH terms:
Fever
Ovarian Neoplasms
Body Temperature Changes
Signs and Symptoms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on July 22, 2014